Idence of 6.1 per 100 person-years) and 60 were in the placebo group (incidence of 5.6 per 100 person-years). There was no significant difference in time to HSV-2 incidence among participants assigned to the FTC/TDF arm compared with those assigned to the placebo arm (HR 1.1, 95 CI: 0.8?.5; P = 0.64; Figure 2). Compared with participants in the placebo arm, there was also no difference in time to
Idence of 6.1 per 100 person-years) and 60 were in the placebo group (incidence of 5.6 per 100 person-years). There was no significant difference in time to HSV-2 incidence among participants assigned to the FTC/TDF arm compared with those assigned to the placebo arm (HR 1.1, 95 CI: 0.8?.5; P = 0.64; Figure 2). Compared with participants in the placebo arm, there was also no difference in time to
N, transgender identity, alcohol use, or sexual behaviors.FTC/TDF and ulcer occurrenceA total of 1,019 participants tested seropositive for HSV-2 at baseline or during follow-up; of those, 22 (2.2 ) tested seropositive for HSV-2 after HIV seroconversion. Among the remaining 997,Daily Oral FTC/TDF PrEP and HSV-2 among MSMTable 1. Characteristics of participants testing HSV-2 seronegative at baselin
Aseline by age group at enrollment, while Figure 1b shows HSV-2 incidence during follow-up by age group at enrollment. HSV-2, herpes simplex virus type 2. doi:10.1371/journal.pone.0091513.gDiscussionIn this analysis of participants in the iPrEx trial of daily oral FTC/TDF PrEP, we found no association between FTC/TDF and incidence of HSV-2 infection, even after accounting for actual use of FTC/TDF
No differences by randomization group in the proportion of participants with 1 STI examination during which a perianal ulcer (FTC/TDF 3.5 vs. placebo 4.7 , P = 0.37) or groin ulcer (FTC/TDF 2.5 vs. placebo 1.9 , P = 0.51) was identified; results were similar after excluding participants with a positive syphilis rapid plasma reagin test at the same visit. However, symptoms that prompted STI exam
D ,25 years (7.1 per 100 person-years) and the lowest rate among participants aged 40 years (1.6 per 100 person-years; P trend = 0.001). Country of residence was also associated with HSV-2 incidence, with theDaily Oral FTC/TDF PrEP and HSV-2 among MSMthere were 72 ulcer AEs classified as Grade 2 or above, with 43 participants (4.3 ) having 1 ulcer AE. Among the 72 ulcer AEs, 23 (31.9 ) were conf
D ,25 years (7.1 per 100 person-years) and the lowest rate among participants aged 40 years (1.6 per 100 person-years; P trend = 0.001). Country of residence was also associated with HSV-2 incidence, with theDaily Oral FTC/TDF PrEP and HSV-2 among MSMthere were 72 ulcer AEs classified as Grade 2 or above, with 43 participants (4.3 ) having 1 ulcer AE. Among the 72 ulcer AEs, 23 (31.9 ) were conf
O predict the probability of having detectable drug and the probability that the level of tenofovir diphosphate (TFV-DP) in PBMCs was .16 fmol per million viable cells, the concentration associated with an estimated 90 reduction in HIV acquisition. [15] Drug levels were multiply imputed [16] for visits at which drug level testing was not conducted but the participant was still taking study drug,